MAUDE Adverse Event Report: MALLINCKRODT MANUFACTURING LLC INOMAX DSIR PLUS (DELIVERY SYSTEM); NITRIC OXIDE ADMINISTRATION APPARATUS,

Model Number	10074
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportable malfunction with inomax dsir plus (b)(6) was documented and investigated under (b)(4).The device was returned to a regional service center (rsc) for evaluation.A review of the device's service log revealed that a low no alarm occurred in conjunction with zero flow measured by the connected injector module (im).Testing of the returned device did not reproduce the low no alarm observed in the device's service log.Further inspection of the returned device identified that pin 6 of the dsir plus head's im cable receptacle was damaged.The root cause for the low no alarm was likely due to a damaged im cable receptacle pin.As a result, the device's im cable receptacle was replaced.Trends were reviewed for this reportable condition and determined to be within the established control limits.No further action is required at this time.A full functional test was performed and the device operated according to specifications.As a result, the device was placed back into circulation for customer use.
Event or Problem Description
A customer located in the united states contacted keenova on (b)(6) 2026 to report the injector module receptacle was damaged on their inomax dsir plus device.There was no report of patient harm associated with this event.The complaint device was returned for investigation.An internal employee performed a service order review for inomax dsir plus (b)(6).Pin 6 of the device's injector module (im) receptacle cable was observed to be damaged.In addition, a service log review identified a low no alarm with zero im flow.This service log finding meets the criteria of a reportable malfunction as it was located at a user's facility and set to administer a dose of inhaled nitric oxide (no) at the time of the event.

• Brand Name: INOMAX DSIR PLUS (DELIVERY SYSTEM)
• Common Device Name: NITRIC OXIDE ADMINISTRATION APPARATUS,
• Manufacturer (Section D): MALLINCKRODT MANUFACTURING LLC; 6603 femrite drive; madison WI
• Manufacturer (Section G): MALLINCKRODT MANUFACTURING LLC; 6603 femrite drive; madison WI
• Manufacturer Contact: mark wendelken ; 440 us route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 25653866
• Report Number: 3004531588-2026-00035
• Device Sequence Number: 12228580
• Product Code: MRN
• UDI-Device Identifier: 00867538000113
• UDI-Public: (01)00867538000113
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown